Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project

Atherosclerosis of Native Arteries of the Extremities Clinical Trial

— MAJESTIC  

Official title:

Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project With Boston Scientific's Innova Drug Eluting Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820637
• Other study ID #: S2049
• Status: Completed
• Phase: N/A
• Start date: August 23, 2013
• Est. completion date: February 20, 2017

Study information

• Verified date: December 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether the Boston Scientific nitinol drug-eluting stent shows acceptable performance at 9 months when treating Superficial Femoral (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 20, 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects age 18 and older

• Subject (or Legal Guardian if applicable) has signed the consent form and is willing and able to provide consent before any study-specific tests or procedures are performed and agrees to attend all required follow-up visits

• Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

• Stenotic, restenotic (from angioplasty only, previous treatment with drug coated balloon is not allowed) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:

1. Degree of stenosis =70% by visual angiographic assessment

2. Vessel diameter = 4 and = 6mm

3. Total lesion length (or series of lesions) =30 mm and =110 mm

• (Note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)

4. Target lesion located at least three centimeters above the inferior edge of the femur

• Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Native Arteries of the Extremities

Intervention

Device:
• The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)
Drug-eluting SFA self-expanding stent

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Prince of Wales Hospital	Randwick
Austria	Allgemeines Krankenhaus AKH	Vienna, Austria
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	Ziekenhuis Oost Limburg	Genk
Belgium	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen
Germany	Universitäts-Herzzentrum Freiburg Bad Krozingen GmbH	Bad Krozingen
Germany	Ev. Luth. Diakonissenanstalt Flensburg	Flensburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universität Leipzig	Leipzig
New Zealand	Auckland City Hospital	Auckland
New Zealand	Braemar Hospital	Hamilton
New Zealand	Middlemore Hospital	Otahuhu

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Germany,  New Zealand, 

References & Publications (1)

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Composite of Major Adverse Events	The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months.	9 months
Primary	Primary Patency	Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.	9-months